New Technique for Uretero-ileal Anastomosis for Patient With Bladder Cancer Who Are Suitable for Orthotopic Neobladder

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Procedure: uretero ileal anastomosis in single trough

• Registration Number: NCT04162093
• Lead Sponsor: Ain Shams University

Brief Summary

there are many techniques for uretero-ileal anastomosis some of them are antirefluxing for protection of the upper urinary tract with many complications including strictures and pyelonephritis with difficult technical issues and long operation time so a modified technique combining the 2 ureter by wallace technique and implanted them in a single trough in the neobladder making the surgery easier and shorter.

this technique was done after informed consent in 45 patients with muscle invasive bladder cancer candidate for radical cystectomy and ileal neobladder diversion

Detailed Description

This was a prospective study conducted from 2014 to 2017 in Ain shams university, 73 patients were enrolled from outpatient clinic diagnosed with muscle invasive bladder cancer and candidate for radical cystectomy and orthotopic urinary diversion, 45 patients were included according to patient's acceptance and the inclusion and exclusion criteria.

After having a written informed consent, all selected patients were assessed by detailed history and physical examination, contrast enhanced pelvi-abdominal Computed tomography (CT) scan (for patients with serum creatinine \<1.5 mg/dl). Laboratory investigations in the form of complete blood count, coagulation profile, electrolytes, renal and liver function tests. Bowel preparation was done to all patients one or two days before operation.

Cases were diverted using a U-shaped pouch with uretero-ileal anastomosis done in a single trough combining the extramural serous-lined tunnel and Wallace techniques.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2017-11
• Study Completion: 2018-09
• Status Verified: 2019-11
• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Last Update Submitted: 2019-11-13
• Study First Posted: 2019-11-14
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single trough	uretero ileal anastomosis in single trough	-

Primary Outcome Measures

Name	Time	Method
the rate of vesicoureteral reflux (VUR)	after 6 months and after one year	the incidence of occurrence of reflux in the patients was assessed
the post operative changes in the mean serum creatinine level	after 6 months and after one year	the change in mean serum creatinine level of the patients was assessed
the incidence of anastomotic stricture	after 6 months and after one year	the incidence of occurrence of uretero ileal stricture in the patients was recorded

Secondary Outcome Measures

Name	Time	Method
the incidence of pyelonephritis	after 6 months and after one year
the incidence of urinary incontinence	after 6 months and after one year
the mean operative time of urinary diversion	at the time of the operation	the time elapsing from bowel selection till the beginning of wound closure